The Chinese pharmaceuticals industry suffered another blow on Monday (July 23) following reports that hundreds of thousands of children may have been inoculated with faulty vaccines from major drug producer Changchun Changsheng Biotechnology.
Agency reports reveal that Chinese police have detained the chairwoman of the company, Gao Junfang along 14 others on Tuesday. Their detention came hours after Chinese president Xi Jinping declared that the drugmaker had broken laws and regulations.
Changchun Changsheng Biotechnology was reported to have forged data during the production of 110,000 rabies vaccines and sold more than 250,000 “substandard” diphtheria, tetanus and pertussis (DTP) vaccines to medical centres last year.
It was unclear how many people had been injected with the faulty vaccines or what the effects of receiving them might be.
The incident has reignited long-held fears over fake medicine and distrust in China’s scandal-plagued health and food authorities. In 2008, six children died and 300,000 became unwell after drinking contaminated milk powder formula. In 2016, $90 million worth of improperly stored vaccines were found to have been sold around the country, while last week, a cardiac drug was recalled after a European medical regulator discovered that it contained an impurity linked to cancer.
Many of the defective vaccines were already on the market and being given to Chinese children, as part of the mandatory national vaccination program. A number have now been recalled, but there is no information at this stage as to how they could affect the health of those children who have already been injected.
At least two different vaccines – rabies, and diphtheria and tetanus (DPT) – manufactured by Changchun Changsheng Biotechnology are known to be defective.
State-run Xinhua news agency reports that at least 113,000 doses of the company’s rabies vaccine are affected.
In a statement, the Jilin Provincial Food and Drug Administration said a total of 253,338 doses of Changsheng’s DPT vaccine were faulty. This batch was sold to the Shandong Provincial Disease Prevention and Control Center.
It follows an earlier incident, in November 2017, when at least another 400,000 doses of the same vaccine, produced by a different, second company, the Wuhan Institute of Biological Products, were found to be substandard.
Eight provinces or cities immediately announced they would be stopping or suspending the use of human rabies vaccine from Changsheng, while another four claimed they had never used it.
It is not known whether other regional disease control agencies have been affected.
The Changsheng vaccine issues first became public following an official government inspection of the company’s facilities on July 15, in which authorities found that the company had fabricated production and testing records, falsified production specifications and equipment, CFDA officials said in a briefing on Sunday.
Despite being overseas on Monday on a visit to Africa, President Xi was briefed on the vaccine crisis and said ensuring the safety of drugs was the responsibility of the government and the Communist Party.
He called for authorities to “scrape the poison off the bone” in their efforts to rectify the vaccine problems.
On Sunday, Premier Li Keqiang, the country’s number two leader, announced a “thorough” investigation of China’s vaccine production and sales process, saying the incident had “broke people’s moral bottom line.”
“Those involved will be resolutely punished with zero tolerance. (The government) will resolutely crack down on all illegal and criminal acts that endanger the safety of people’s lives,” a statement released by China’s Central Government said.
The vaccine crisis will undermine attempts by authorities to rebuild the public’s trust in Chinese food and medicines after a series of wide-scale controversies in the past decade.
In a statement released to the Shenzhen Stock Exchange, the management of Changsheng said it felt “very ashamed and guilty” over the vaccines.
“The company will learn a lesson and take practical corrective measures and rectify thoroughly,” the statement said.
For their mistake, Changsheng was fined 3,442,887 yuan ($507,843) by the Chinese government.
